DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In the reply filed 4/20/2026, Applicant cancelled claims 1-20 and added new claims 21-38. Claims 21-38 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Species C: Figure 4 in the reply filed on 4/20/2026 is acknowledged. Newly added claims 21-38 read on the elected species.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a flow diversion mechanism in claims 28, 29, and 35.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-23, 27, 28, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martinez (US 2014/0228733).
With respect to Claim 21, Martinez teaches a method of increasing flow through a left atrial appendage (see Abstract) comprising:
creating a passageway (32, 62) traversing through a wall of a pulmonary vein (PV) 20 and a wall of the left atrial appendage (LAA) 24 (see the embodiments of Figures 2 and 4-6); and
diverting flow from the pulmonary vein directly into the left atrial appendage through the passageway via a path of least resistance such that the flow passes into the left atrial appendage and washes out the left atrial appendage (see Abstract, [0001], and [0016-0024]; the examiner notes that fluid will naturally flow via the path of least resistance, and therefore any blood that passes through the passageway does so because it is the passageway of least resistance).
With respect to Claim 22, Martinez teaches that creating the passageway traversing through the wall of the pulmonary vein and the wall of the left atrial appendage comprises placing a flow diverter (32, 62) in the pulmonary vein that leads directly into the left atrial appendage (Figures 2 and 4-6). Specifically, the flow diverter is a conduit (32, 62) that extends through the walls of the PV and LAA to form a fluid connection therebetween.
With respect to Claim 23, Martinez teaches that the upstream end of the flow diverter (32, 62; Figures 2 and 4-6) is positioned in the PV upstream of a left lateral ridge.
With respect to Claim 27, Martinez teaches that blood is diverted from the PV, through the passageway, and into the LAA (Figures 2 and 4-6; Abstract, [0001], and [0016-0024]). The examiner notes that fluid will naturally flow via the path of least resistance, and therefore any blood that passes through the passageway does so because it is the passageway of least resistance. Accordingly, Martinez teaches the step of resistively diverting flow from the PV directly into the left atrial appendage.
With respect to Claim 28, Martinez teaches a method of increasing a blood flow through a left atrial appendage (Abstract), comprising:
sizing a diameter and a length of a flow diversion mechanism (32, 62) to ensure washout of a left atrial appendage (the flow diversion mechanism 32/62 is sized such that it is configured to wash out the LAA using blood from transferred from the PV; Figures 2 and 4-6; Abstract and paragraphs [0001] and [0016-0024])
connecting an inlet of the flow diversion mechanism (32, 62) to a pulmonary vein 20 such that the inlet of the flow diversion mechanism extends through a wall of the pulmonary vein 20 (see the embodiments of Figures 2 and 4-6);
connecting an outlet of the flow diversion mechanism to the left atrial appendage 24 such that the outlet of the flow diversion mechanism extends through a wall of the left atrial appendage 24 (Figures 2 and 4-6); and
wherein the flow diversion mechanism actively causes at least a portion of the blood to flow through the flow diversion mechanism into the left atrial appendage to wash out the left atrial appendage (see Abstract, [0001], and [0016-0024]).
With respect to Claim 36, Martinez teaches a method of increasing a blood flow through a left atrial appendage (Abstract), comprising:
penetrating through a wall of a pulmonary vein 20 (Figures 2 and 4-6; [0024]);
penetrating through a wall of a left atrial appendage 24 (Figures 2 and 4-6; [0024]);
creating a passageway (32, 62; Figures 2 and 4-6) traversing through the wall of the pulmonary vein 20 and the wall of the left atrial appendage 24 (Abstract; paragraphs [0001] and [0016-0024]);
wherein an inlet of the passageway extends through the wall of the pulmonary vein (Abstract);
wherein an outlet of the passageway extends through the wall of the left atrial appendage (Abstract); and
deliberately deflecting at least a portion of the blood flow from the pulmonary vein directly into the left atrial appendage through the passageway such that the at least a portion of the blood flow passes into the left atrial appendage and washes out the left atrial appendage (Figures 2 and 4-6; Abstract; paragraphs [0001] and [0016-0024]; the examiner notes that blood is directed through the implanted passageway and is therefore “deliberately deflected”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 24, 29, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Martinez. Martinez teaches the methods of Claims 21, 28, and 36 as set forth above, but does not specifically teach that the diverting flow step comprises diverting a majority of the blood. Specifically, Martinez is silent as to the portion of blood that is diverted.
However, it has been held that mere changes in size or proportion do not constitute patentable improvements in the art when said changes do not result in a non-obvious change in functionality (see MPEP § 2144.04.IV.A.). In this case, a skilled artisan would have understood that changing the size of the passageway would result in a change in the proportion of blood that passes through it, and therefore would have understood that the passageway/s diameter could be changed to create a desired flow rate/proportion. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the size of the passageway in Martinez’s method cause a majority, or any other amount of the blood to be diverted through the passageway that was considered desirable for a given application, in order to modify the flow rate of blood into the LAA according to the specific needs of a given patient.
Claims 25, 26, 30, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Martinez as applied to claims 21, 28, and 36 above, and further in view of Zimmerman (US 2015/0328026).
With respect to Claims 25, 26, 30, and 32-34, Martinez teaches the methods of Claims 21, 28, and 36 substantially as claimed, but does not specifically teach that the method further comprises implanting a flow resistor downstream of the passageway/flow diverter (Claims 25 and 30) near the left lateral ridge (Claims 26 and 32), the flow resistor comprising a braided stent (Claims 33-34).
Zimmerman teaches a method of increasing flow through a LAA comprising diverting flow from a pulmonary vein 1212 into a LAA 1214 by creating a passageway therebwetween (Figure 13), specifically placing a tubular passageway 1200 between the PV and the LAA. Specifically, the device comprises a flow diverter 1216 and a flow resistor 1208 positioned downstream of the flow diverter (Figure 13) near the left lateral ridge. The flow resistor 1208 comprises a braided stent with reduced-diameter outlet, such that increased flow resistance causes blood to exit the passageway at a higher velocity, thereby minimizing or preventing flow stagnation in the LAA (see Figure 13; paragraphs [0074] and [0111]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Martinez’s method to use a flow resistor downstream of the passageway near the left lateral ridge, the flow resistor comprising a braided stent, as suggested by Zimmerman, in order to provide well-known means for increasing the outlet velocity of blood exiting the flow diverter, thereby preventing flow stagnation in the LAA.
The examiner notes that the rejection of Claims 26 and 32 can be overcome by specifying placing the flow resistor in the pulmonary vein downstream of the passageway/flow diverter.
With respect to Claim 35, Martinez does not specifically teach that the outlet of the flow diverter is oriented toward a sidewall of the LAA such that the blood flow creates a vortex within the LAA. However, Zimmerman teaches a method for increasing flow through the LAA by inserting a shunt that redirects flow from the PV into the LAA (Figure 1A). Specifically, the shunt is curved so as to direct flow along the sidewall of the LAA, (see flow arrows in Figure 1A), thereby causing flow along the wall of the LAA and preventing flow stagnation and thrombus formation in the LAA [0074]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Martinez’s method to divert flow toward a sidewall of the LAA, as suggested by Zimmerman, in order to cause flow along the wall of the LAA and prevent flow stagnation and thrombus formation in the LAA.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,559,672. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of increasing blood flow through a left atrial appendage comprising the steps of creating a passageway through the wall of the PV and a wall of the LAA using a flow diverter, and diverting blood flow into the LAA to wash out the LAA. The instant claims are broader than the ‘672 claims because they do not specifically require the step of resistively diverting blood through the passageway such that a majority of the blood from the PV passes through the passageway (Claims 21 and 28), or that a separate flow resistor is placed downstream of the flow diverter (Claim 36).
With specific respect to Claim 28, the ‘672 claims do not explicitly require the step of sizing a flow diversion mechanism to ensure washout of a LAA. However, since both claimed methods perform this function, it is implicit that the flow diversion mechanism is sized for the claimed purpose.
Claims 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,904,120. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of increasing blood flow through a left atrial appendage comprising creating a passageway from the PV to the LAA by connecting the inlet of a flow diverter to the PV and the outlet of the flow diverter to the LAA, and diverting flow into the LAA to cause blood flow to wash out the LAA. The instant claims are broader than the ‘120 claims because they do not necessarily require that blood is actively diverted through the passageway/flow diverter.
With specific respect to Claim 28, the ‘120 claims do not explicitly require the step of sizing a flow diversion mechanism to ensure washout of a LAA. However, since both claimed methods perform this function, it is implicit that the flow diversion mechanism is sized for the claimed purpose.
Allowable Subject Matter
Claims 13 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and upon filing a terminal disclaimer to overcome the double patenting rejections set forth above.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art does not teach or suggest the claimed flow increasing methods wherein the flow resistor is separate from the flow diverter (Claim 13), or wherein the flow resistor is in the PV downstream of the passageway.
The closest prior art (Martinez and Zimmerman) does not teach or suggest placement of a flow resistor in the PV downstream of the passageway/flow diverter (i.e. such that they are formed separately. It is unclear why one of ordinary skill in the art would have modified the PV-to-LAA shunts of Martinez or Zimmerman to have the claimed features.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Peavey et al. (US 2005/0234540) teaches a dilation stent for increasing blood flow in the LAA.
Kapadia (US 2012/0022427) teaches a method of using a catheter to increase blood flow in the LAA.
Chanduszko et al. (US 7,806,846) teaches a shunt for restoring flow in the LAA.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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